Post-cardiac SurgeryNCT05285098
Leipzig FAST-TRACK Over 15 Years for Cardiac Surgical Patients
An observational study of Post-cardiac Surgery, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
Trial summary
Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-cardiac Surgery
- How many people
- 20,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: -All consecutive cardiac surgical patients treatet with Leipzig fast-track protocol
Who may be able to join
- Adults >18y
Who cannot join
- Incomplete data
- Catheter-valve implantation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Leipzig Heart center
Leipzig, Saxony, 04289
Waseem Zakhary, Dr, 0049341865254024, waseemzakariaaziz.zakhary@medizin.uni-leipzig.de
About this study
Official title: Retrospective Analysis of 15 Years of Leipzig "Fast-Track" Concept.
Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the fast track evolutions.
Read the detailed description
Fast Track Treatment includes many elements recommended by the ERAS Society for cardiac surgery(1). Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The patients are transferred from the operation room to the recovery room, extubated there within a short time, stabilized and transferred on the same day to intermediate care (IMC). Ideally, the patient will be transferred to the normal ward on the first postoperative day. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the evolutions within the fast-track protocol over a period of 15 years (from November 2005 to December 2020).
- Conditions
- Post-cardiac Surgery
- Keywords
- Fast track after cardiac surgery, ERAS cardiac surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
FT evolution analysis in complexity
Trends analysis in complexity ( using EUROSCORE II) against time (in years)
Measured: Novmber 2005- December 2020
FT evolution analysis in length of stay
Trends analysis of length of stay ( in hospital and ICU in days) against time (in years)
Measured: Novmber 2005- December 2020
FT evolution analysis in postoperative complications
Trends analysis in postoperative complications ( cardiac, pulmonary, and neurological) in percentage against time ( in years)
Measured: Novmber 2005- December 2020
FT evolution analysis in postoperative mortality rate
Trends analysis of postoperative mortality rate ( in percentage) against time (in years)
Measured: Novmber 2005- December 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Apr 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heart Center Leipzig - University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg Ender, Study chair, Leipzig Heart center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285098
- Sponsor's protocol ID
- FT15
- Status last verified
- Mar 2022
- First submitted
- 31 Jan 2022
- Last updated
- 17 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Retrospective analysis of the data ( collected from the hospital clinical information systems) for all consecutive patients admitted to PACU during 15 years.
Publications
Ender J, Borger MA, Scholz M, Funkat AK, Anwar N, Sommer M, Mohr FW, Fassl J. Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept. Anesthesiology. 2008 Jul;109(1):61-6. doi: 10.1097/ALN.0b013e31817881b3.
PubMed 18580173Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
PubMed 31054241Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.
PubMed 27616189
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of 15 Years of Leipzig "Fast-Track" Concept.
- ClinicalTrials.gov ID
- NCT05285098
- Acronym / sponsor ID
- FT15
- Conditions
- Post-cardiac Surgery
- Keywords
- Fast track after cardiac surgery, ERAS cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Heart Center Leipzig - University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the fast track evolutions.
Detailed description
Fast Track Treatment includes many elements recommended by the ERAS Society for cardiac surgery(1). Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The patients are transferred from the operation room to the recovery room, extubated there within a short time, stabilized and transferred on the same day to intermediate care (IMC). Ideally, the patient will be transferred to the normal ward on the first postoperative day. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the evolutions within the fast-track protocol over a period of 15 years (from November 2005 to December 2020).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- -All consecutive cardiac surgical patients treatet with Leipzig fast-track protocol
Key inclusion criteria (1 listed)
- Adults >18y
Key exclusion criteria (2 listed)
- Incomplete data
- Catheter-valve implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
FT evolution analysis in complexity
Time frame: Novmber 2005- December 2020
Trends analysis in complexity ( using EUROSCORE II) against time (in years)
FT evolution analysis in length of stay
Time frame: Novmber 2005- December 2020
Trends analysis of length of stay ( in hospital and ICU in days) against time (in years)
FT evolution analysis in postoperative complications
Time frame: Novmber 2005- December 2020
Trends analysis in postoperative complications ( cardiac, pulmonary, and neurological) in percentage against time ( in years)
FT evolution analysis in postoperative mortality rate
Time frame: Novmber 2005- December 2020
Trends analysis of postoperative mortality rate ( in percentage) against time (in years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Background: PubMed 18580173Ender J, Borger MA, Scholz M, Funkat AK, Anwar N, Sommer M, Mohr FW, Fassl J. Cardiac surgery fast-track treatment in a postanesthetic care unit: six-month results of the Leipzig fast-track concept. Anesthesiology. 2008 Jul;109(1):61-6. doi: 10.1097/ALN.0b013e31817881b3.
- Background: PubMed 31054241Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
- Background: PubMed 27616189Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.
- Individual participant dataSharing planned: Undecided. Retrospective analysis of the data ( collected from the hospital clinical information systems) for all consecutive patients admitted to PACU during 15 years.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joerg Ender study chair
Leipzig Heart center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-cardiac Surgery, run by Heart Center Leipzig - University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waseem Zakhary, Dr. (0049341865254024, waseemzakariaaziz.zakhary@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FT evolution analysis in complexity (time frame: Novmber 2005- December 2020). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05285098, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.